What is DOTS?

Tuberculosis is completely curable through short-course chemotherapy. Treating TB cases who are sputum-smear
positive (and who can therefore spread the disease to others) at the source, it is the most effective means of
eliminating TB from a population.
 
DOTS or Directly Observed Treatment Short course is the internationally recommended strategy for TB control that
has been recognized as a highly efficient and cost-effective strategy. DOTS comprises five components:
 

1.       Sustained political and financial committment. TB can be cured and the

epidemic reversed if adequate resources and administrative support for TB
control are provided.

2.      Diagnosis by quality ensured sputum-smear

microscopy. Chest symptomatics examined this way helps to reliably find
infectious patients.

3.      Standardized short-course anti-TB treatment (SCC) given under direct

and supportive observation (DOT). 
Helps to ensure the right drugs are taken at the right time for the full duration
of treatment.
 

4.      A regular, uninterrupted supply of high quality anti-TB drugs.

Ensures that a credible national TB programme does not have to turn anyone
away.

5.      Standardized recording and reporting

Helps to keep track of each individual patient and to monitor
overall programme performance.
 

 
The new global Stop TB Strategy builds on the DOTS strategy, which remains the fundamental basis for TB control.
The six additional essential elements in the new strategy are:
1.      Sustaining, improving and accelerating quality DOTS expansion
2.      Addressing TB-HIV, MDR-TB and other special challenges
     TB/HIV collaborative interventions
      DOTS-Plus for MDR-TB

     Reaching vulnerable, high risk groups

3.      Contributing to health system strengthening

     TB control innovations that strengthen health systems

     Adaptation of innovations from other TB control programmes

     Practical Approach to Lung Health

4.      Engaging all care providers

     Public-private partnerships

     Ensuring equitable access to international standards of care for TB to all

5.      Empowering patients and communities

     Advocacy, communication and social mobilisation

     Community based TB care

6.      Enabling and promoting research

     Programme-based operational research

     Development of new diagnostics, drugs and vaccines

 Pursue high-quality DOTS expansion and enhancement

LHIL/JP Zellweger

DOTS remains at the heart of the Stop TB Strategy. To enable known constraints to be addressed and new
challenges met, further strengthening of the basic five components of the DOTS approach is required.

Five components of DOTS:

 1. Political commitment with increased and sustained financing
Legislation, planning, human resources, management, training
 2. Case detection through quality-assured bacteriology
Strengthening TB laboratories, drug resistance surveillance
 3. Standardized treatment with supervision and patient support
TB treatment and programme management guidelines, International Standards of TB Care (ISTC), PPM, Practical
Approach to Lung Health (PAL), community-patient involvement
 4. An effective drug supply and management system
Availability of TB drugs, TB drug management, Global Drug Facility (GDF), Green Light Committee (GLC)
 5. Monitoring and evaluation system and impact measurement
TB recording and reporting systems, Global TB Control Report, data and country profiles, TB planning and
budgeting tool, WHO epidemiology and surveillance online training

Pursue high-quality DOTS expansion and enhancement

Element 1: Political commitment with increased and sustained financing
Clear and sustained political commitment by national governments is crucial if basic DOTS1 and the Stop TB
Strategy are to be effectively implemented. Political commitment is needed to foster national and international
partnerships, which should be linked to long-term strategic action plans prepared by national TB control
programmes (NTPs). Strategic action plans should address technical and financial requirements and promote
accountability for results at all levels of the health system; they should include TB-related and other relevant
indicators, and - where appropriate - political commitment should be backed up by national legislation.2Local
partnerships with many potential contributors will help improve TB care in terms of access, equity and quality.
Adequate funding is essential. Current resources are inadequate, and further effort is required to mobilize additional
resources from domestic as well as international sources, with a progressive increase in domestic funding. The
global financing and partnership resources now available for poverty reduction, health systems improvement and
disease control offer new opportunities for TB control programmes. Even with adequate financing, critical
deficiencies in human resources in the health sector will impede progress in many low- and middle-income
countries, especially in Africa. Political commitment is required to support the overall structural and financial
changes needed to improve the availability, distribution and motivation of competent health workers. Special efforts,
including good strategic planning, will be needed to ensure the availability of adequate and competent human
resources for health care in general and TB care in particular
Pursue high-quality DOTS expansion and enhancement
Element 2: Case detection through quality-assured bacteriology
 Bacteriology for diagnosis
Bacteriology remains the recommended method of TB case detection, first using sputum smear microscopy and then
culture and drug susceptibility testing (DST), as indicated below.
 Policy statement: Molecular line probe assays for rapid screening of patients at risk of multidrug-resistant
tuberculosis (MDR-TB)
pdf, 78kb
Strengthened laboratory network
A wide network of properly equipped laboratories with trained personnel is necessary to ensure access to quality-
assured sputum smear microscopy. This is likely to require additional investments in the laboratory network in many
countries. In addition, every country should have a well-resourced and fully functioning national reference
laboratory.
The laboratory network should be based on the following principles:
 adoption of national standards in accordance with international guidelines;
 decentralization of diagnostic services, with high proficiency levels maintained;
 communication among members at various levels of the network; and
 functioning internal and external quality management, including supervision
Culture and DST services should be introduced, in a phased manner, at appropriate referral levels of the health
system. Their functions should include diagnosis of sputum smear-negative TB, diagnosis of TB among HIV-
positive adults and children, diagnosis and monitoring of response to treatment of MDR-TB, and testing related to
periodic surveys of the prevalence of drug resistance. Maintaining the quality of the laboratory network depends on
regular training, supervision and support, and motivation of laboratory staff. Best use should be made of existing
public and private laboratories.
Pursue high-quality DOTS expansion and enhancement
Element 3: Standardized treatment, with supervision and patient support
RELATED DOCUMENTS
1
Treatment of tuberculosis: guidelines for national programmes
Various languages

2
Guidelines 
for the programmatic management of drug-resistant tuberculosis
Various languages

Treatment services
The mainstay of TB control is organizing and administering standardized treatment across the country for all adult
and paediatric TB cases – sputum smear-positive, smear-negative, and extrapulmonary. In all cases, WHO
guidelines on patient categorization and management should be followed.1 These guidelines emphasize use of the
most effective standardized, short-course regimens, and of fixed-dose drug combinations (FDCs) to facilitate
adherence to treatment and to reduce the risk of the development of drug resistance. Separate WHO guidelines are
also available for management of patients with drug-resistant TB.2
 Supervision and patient support
Services for TB care should identify and address factors that may make patients interrupt or stop treatment.
Supervised treatment, which may have to include direct observation of therapy (DOT), helps patients to take their
drugs regularly and complete treatment, thus achieving cure and preventing the development of drug resistance.
Supervision must be carried out in a context-specific and patient-sensitive manner, and is meant to ensure adherence
on the part both of providers (in giving proper care and support) and of patients (in taking regular treatment).
Depending on the local conditions, supervision may be undertaken at a health facility, in the workplace, in the
community or at home. It should be provided by a treatment partner or treatment supporter who is acceptable to the
patient and is trained and supervised by health services. Patient and peer support groups can help to promote
adherence to treatment. Selected patient groups, for example prisoners, drug users, and some people with mental
health disorders, may need intensive support including DOT.
Improving access to treatment
Locally appropriate measures should be undertaken to identify and address physical, financial, social and cultural
barriers – as well as health system – barriers to accessing TB treatment services. Particular attention should be given
to the poorest and most vulnerable population groups. Examples of actions that may be appropriate include
expanding treatment outlets in the poorest rural and urban settings, involving providers who practise close to where
patients live, ensuring that services are free or heavily subsidized, offering psychological and legal support,
addressing gender issues, improving staff attitudes, and undertaking advocacy and communication activities.
Pursue high-quality DOTS expansion and enhancement
Element 4: An effective drug supply and management system
RELATED DOCUMENTS

 1
 4 million treatments in
4 years. Achievement report [pdf 416kb]

 What is DOTS?
 Global Drug Facility (GDF)
 Green Light Committee (GLC) Initiative
An uninterrupted and sustained supply of quality-assured anti-TB drugs is fundamental to TB control. For this
purpose, an effective drug supply and management system is essential. A reliable system of procurement and
distribution of all essential anti-TB drugs to all relevant health facilities should be in place. The TB recording and
reporting system is designed to provide the information needed to plan, procure, distribute and maintain adequate
stocks of drugs.
Anti-TB drugs should be available free of charge to all TB patients, both because many patients are poor and may
find them difficult to afford, and because treatment has benefits that extend to society as a whole (cure prevents
transmission to others). Legislation related to drug regulation should be in place, and use of anti-TB drugs by all
providers should be strictly monitored. The use of FDCs of proven bioavailability and of innovative packaging such
as patient kits can help to improve drug supply logistics as well as drug administration, promote adherence to
treatment and prevent development of drug resistance.
The Stop TB Partnership's Global Drug Facility and the Green Light Committeeoffer countries with limited capacity
the benefit of access to quality-assured TB drugs at reduced prices and also facilitate access to training on drug
management.1
Pursue high-quality DOTS expansion and enhancement
Element 5: Monitoring and evaluation system, and impact measurement
Recording and reporting system
Establishing a reliable monitoring and evaluation system with regular communication between the central and
peripheral levels of the health system is vital. This requires standardized recording of individual patient data,
including information on treatment outcomes, which are then used to compile quarterly treatment outcomes in
cohorts of patients.
These data, when compiled and analysed, can be used at the facility level to monitor treatment outcomes, at the
district level to identify local problems as they arise, at provincial or national level to ensure consistently high-
quality TB control across geographical areas, and nationally and internationally to evaluate the performance of each
country. Regular programme supervision should be carried out to verify the quality of information and to address
performance problems.
Enhanced recording and reporting
Both developed and developing countries now have additional diagnostic information at their disposal, including
sputum culture, DST and HIV test results, all of which can be used to guide patient management. TB programme
managers also need to monitor records and reports from public and private care providers not directly linked to the
national TB programme (NTP). Special attention must be paid to ensuring the confidentiality of patient information.
Use of electronic recording systems will be considered where appropriate.
Making the best use of data at all levels will mean many countries having to train staff in the analysis and
interpretation of data, as well as in the use of the computer software that can greatly facilitate this work. As
electronic recording systems become more widely available, consideration should be given to storing individual
patient data, which will make more detailed analyses of aggregated data possible.
WHO's report on Global TB Control compiles data from 200 countries each year, monitoring the scale and direction
of TB epidemics, implementation and impact of the Stop TB Strategy, and progress towards the Millennium
Development Goals.
TB impact measurement
TB impact measurement has two major components. The first is measuring the epidemiological burden of TB, and
trends in this burden, in terms of three so-called "impact indicators": incidence (the number of newly-arising cases
of TB each year), prevalence (the number of cases of TB in the population at a given point in time) and mortality
(the number of deaths from TB in a given year). These are the major indicators being used to measure progress in
TB control at global level, for example in the context of targets set within the Millennium Development Goals
(MDGs) and by WHO and the Stop TB Partnership. The second major component of TB impact measurement is
evaluation of the extent to which interventions to control TB are responsible for changes in incidence, prevalence
and mortality (so-called "impact evaluation").
WHO has established the Global Task Force on TB Impact Measurement.
Ethical issues in tuberculosis care and control
Background
Tuberculosis (TB) prevention, care and control raise important ethical and policy issues that need to be adequately
addressed. These concerns have been accentuated by the problem of multidrug-resistant TB (MDR-TB) and, most
recently, by the emergence and spread of “extensively” drug-resistant TB (XDR-TB) which is especially difficult to
detect and treat.
Following the recommendation of the WHO Task Force on XDR-TB at their 2nd meeting (April 2008), the Ethics
and Health Team of the Department of Ethics, Equity, Trade and Human Rights and the Stop TB Department jointly
established aWHO Task Force on Addressing Ethical Issues in TB Care and Control Programmes in August
2008.
 Goal
The aim was to undertake a comprehensive analysis of ethical issues in TB and to lay the groundwork for the
formulation of WHO guidance in order to help governments and other stakeholders to implement TB care and
control programmes in an ethical manner.
Composition of the Task Force
Twenty-two members from a variety of fields, including national TB programmes, civil society, ethics, human
rights, and health law.
Major issues
Discussion papers on the following topics were commissioned:
1. Access to diagnosis and treatment;
2. Obligations and rights of health care workers and patients;
3. Public health measures; and
4. Research.
Development of WHO guidance
The Task Force held its first meeting 8-10 December 2008 at the Joint Center for Bioethics at the University of
Toronto, a WHO Collaborating Center for Bioethics. During the meeting, members discussed the background papers
prepared for the meeting and the main points to be included in the global guidance document.
A second meeting of the Task Force was held 26-28 August 2009 at WHO in Geneva. The goal was to draft an
outline for the WHO guidance document.
On 15 October 2009, a consultation with additional representatives of civil society and national TB programmes
took place in Geneva. The goal was to discuss the outline of the guidance document and to ensure further input and
participation of civil society, national TB programme managers, policy-makers, and field workers.
Currently, the draft WHO document, entitled "Ethical guidance for TB Care and Control Programmes" is being
finalized by the Secretariat and Task Force.
The draft document was presented at the STB department's Strategic and Technical Advisory Group for
Tuberculosis (STAG-TB) in November 2009 and at the 40th Union World Conference on Lung Health in December
2010 in order to receive final input.
In addition, the draft document will be shared with other key stakeholders for comment in order to engage a full
range of end users to ensure the practical interpretation, adaptability and use of the guidance document.
The final guidance document was published in December 2010.
Planned activities for 2011
The development of case studies is planned in order to give concrete examples of ethical dilemmas that decision-
makers face in TB policies and programmes, and to illustrate some of the challenges and solutions proposed in the
guidance document.
Training materials for ethics and TB will be developed and used in workshops for programme managers and other
stakeholders in order to build capacity at the local level.